R

Rocket Pharmaceuticals

Gene therapies for rare inherited diseases

Senior Director - Analytical Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeCranbury, NJ, USAIn-person

About the Job

Requirements

  • A PhD in biochemistry, analytical chemistry, or a related biological science discipline with 10 years of biotechnology or biopharmaceutical industry experience in assay development or related fields in cell or gene therapy; alternatively, an M.S. with 12 years of relevant experience or a BS with 15 years of experience.
  • At least 5 years of leadership experience.
  • Proven experience developing assays to support cell and gene therapy programs in development and GMP environments.
  • Extensive background in developing molecular (PCR), ELISA, HPLC/UPLC, and cell-based potency assays.
  • Significant experience qualifying, verifying, validating, and transferring analytical methods to a QC laboratory setting.
  • Strong understanding of GMP and ICH guidelines.
  • Proficiency in Excel, JMP, and DNA analysis software.
  • Ability to meet deadlines and prioritize multiple projects.
  • Experience leading teams and fostering team-member development.
  • Strong technical writing and oral presentation skills.
  • Strong responsibility, scientific rigor, accountability, and integrity.
  • Strong time-management skills and ability to prioritize tasks across multiple projects to meet deadlines.

Responsibilities

  • Strategically lead and oversee development and optimization of viral vector downstream and drug product release and characterization methods in preparation for transfer into a GMP environment.
  • Provide analytical support for drug substance process development and drug product development, including process and finished-product characterization and establishing or refining Quality Attribute designations.
  • Review and approve technical documents, standard operating procedures, method transfer, qualification, and validation reports, specifications, and relevant study reports.
  • Provide hands-on leadership and guidance to scientific staff.
  • Foster the development, coaching, and mentoring of a growing team of scientists.

Desired Qualifications

  • Direct experience with AAV or LV technologies, and/or expertise in viral vector biophysical characterization, such as particle distribution analysis, capsid characterization or modification, and viral genome sequencing.

About the Company

Rocket Pharmaceuticals

Gene therapies for rare inherited diseases

Rocket Pharmaceuticals develops gene therapies for rare inherited diseases using viral vectors to deliver a working copy of a gene to patient cells. It utilizes adeno-associated virus (AAV) and lentiviral platforms to target disorders of the heart, blood, and other organs, including Danon disease, arrhythmogenic cardiomyopathy, and Fanconi anemia. The company conducts research, clinical development, and manufacturing of investigational therapies, often in collaboration with clinical and research partners, to bring first treatments to diseases with few or no approved options. Its goal is to provide the first gene-therapy treatments for patients with rare inherited diseases that currently have limited or no approved options.

Company size
201-500
Company stage
IPO
Headquarters
Cranbury Township, New Jersey
Founded
2015

Recently Posted Jobs

Explore more opportunities at Rocket Pharmaceuticals

See more jobs